{"id":2082,"date":"2010-07-21T14:58:58","date_gmt":"2010-07-21T18:58:58","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=2082"},"modified":"2011-07-19T17:44:55","modified_gmt":"2011-07-19T21:44:55","slug":"fda-halts-new-enrollment-in-tide","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/07\/21\/fda-halts-new-enrollment-in-tide\/","title":{"rendered":"FDA Halts New Enrollment in TIDE"},"content":{"rendered":"<p>The FDA has halted new enrollment in\u00a0<a href=\"http:\/\/www.hamiltonhealthsciences.ca\/sitemaker\/websitefiles\/phri532294\/body.cfm?id=247\">TIDE<\/a> (Thiazolidinedione Intervention with Vitamin D Evaluation), the controversial Avandia safety study,\u00a0by placing the study on \u201cpartial clinical hold.\u201d Patients already enrolled in the trial will continue to participate. The <a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm219780.htm\">FDA said in a\u00a0statement<\/a> that it had instructed GlaxoSmithKline to \u201cupdate investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial\u201d with information derived from last week\u2019s advisory panel meeting. Responding to the FDA action, <a href=\"http:\/\/www.gsk.com\/media\/pressreleases\/2010\/2010_pressrelease_10078.htm\">GSK issued a statement<\/a> saying that it would\u00a0\u00a0suspend enrollment of patients in TIDE and \u201cwill work with the TIDE Steering Committee\u201d to send new safety data and a summary of the panel meeting to TIDE investigators and IRBs.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has halted new enrollment in\u00a0TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation), the controversial Avandia safety study,\u00a0by placing the study on \u201cpartial clinical hold.\u201d Patients already enrolled in the trial will continue to participate. The FDA said in a\u00a0statement that it had instructed GlaxoSmithKline to \u201cupdate investigators, institutional review boards (IRBs) and ethics committees [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[199,200,196,197,198],"class_list":["post-2082","post","type-post","status-publish","format-standard","hentry","category-general","tag-avandia","tag-diabetes","tag-fda","tag-tide","tag-tzds"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/2082","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=2082"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/2082\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=2082"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=2082"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=2082"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}